Apparatus and method for the treatment of stress urinary incontinence

ABSTRACT

An apparatus and method for the treatment of stress urinary incontinence. The apparatus includes a suburethral sling having an adjustment member for adjusting the tension of the sling both during the procedure and post-procedure. The method includes using a needle to simultaneously implant the sling and to deliver a local anesthetic in the groin area while implanting the sling.

CROSS REFERENCE TO RELATED APPLICATION

This application claims priority to U.S. Provisional Patent ApplicationSer. No. 60/952,802, filed Jul. 30, 2008, which is hereby incorporatedherein by reference in its entirety for all purposes.

FIELD OF THE INVENTION

The present invention relates generally to the field of medical devices,and in particular to an apparatus and method for treating stress urinaryincontinence in a human or animal subject.

BACKGROUND OF THE INVENTION

Stress urinary incontinence (“SUI”) is a widespread problem throughoutthe world affecting people of all ages and gender. SUI is theinvoluntary leakage of small amounts of urine resulting from anincreased pressure in the abdomen and may result while sneezing,coughing, laughing, bending, lifting, etc. While primarily a femaleproblem, men also suffer from stress urinary incontinence, and rates ofmale SUI are increasing along with the increased use of prostatesurgery. Stress incontinence in men is typically the result of aweakened urethral sphincter that surrounds the prostate, frequently as aresult of prostate surgery.

For treating SUI, it is often necessary to resort to surgery.Conventional techniques consist of restoring the natural mechanisms ofcontinence, maintaining the urethra in the abdominal cavity, and/orincreasing urethral resistance. To do this, a conventional sling isplaced under the urethra, thereby making it possible to improve thesuspension and provide some compression of the urethra. Currently, thereare a variety of different sling procedures which differ in theanchoring methods and materials used.

Despite advances in midurethral sling design over the past years, therestill remains considerable room for improvements, particularly in slingdesign and placement. For example, such procedures typically requirehospitalization. Thus, many females and males with stress urinaryincontinence avoid or delay undergoing an operation. Moreover, althoughserious complications associated with sling procedures are infrequent,they do occur. In some cases, the slings cause friction in the area ofthe vagina or urethra during the patient's movements and may injuredifferent organs with which they are in contact. This friction may thencause erosion, inflammation or infection, or even cause rejection of thesling, thereby requiring another operation to surgically remove thesling.

Other shortcomings of known sling designs include the fact that multipleincisions are typically required to implant a sling, thereby increasingthe patient's level of discomfort and recovery time. Additionally,passage of mesh through the skin or subcutaneous tissue can result inpatient discomfort and therefore most commonly requires generalanesthesia. Moreover, once implanted, the sling cannot be adjusted, andthus if the sling is not implanted in the precise or ideal location, thepatient may continue to have incontinence-related issues. There are somedevices whose use compromises the surgeon's ability to easily andaccurately tension the sling. This is being perceived as a majorshortcoming, and is probably a major reason underlying unacceptableinitial failure rates of approximately 25%.

Accordingly, there exists a need for a sling that satisfactorily treatsstress urinary incontinence and that permits post-operative adjustmentof the sling. Further needs exist for methods for implanting slings thatminimize a subject's discomfort and recovery time and allow forplacement under local anesthesia.

SUMMARY OF THE INVENTION

Advantageously, the present invention provides an adjustable sling (or a‘mini sling’ having minimal mesh arms traveling though hidden anatomicspaces) for treating stress urinary incontinence in both female and malesubjects. Notably, a practitioner can implant the sling in an office orother ambulatory setting using a local anesthetic rather than usinggeneral anesthesia in a hospital setting. Such implantation can beachieved, in the female, by passing the needle from a vaginal incisionout to either the groin area (“inside out transobturator” approach), orsuprapubic region (“inside-out retropubic” approach). In the male, suchimplantation can be achieved by passing the needle from a perinealincision out to the groin area (“inside-out transobturator approach”),which before now has not been described or performed in male subjects.Also advantageously, the sling of the present invention can be adjustedboth during the procedure and at a future a date without furthersurgery, incisions, or puncture wounds. Since the subject is awake (andnot under general anesthesia), the tension of the sling can be adjustedwhile the patient coughs (or engaged in another activity that causesintraabdominal pressure). Additionally, if the sling is not performingoptimally, the practitioner can adjust the tension days after theprocedure.

In a first form, the present invention provides an apparatus for thetreatment of stress urinary incontinence. The apparatus includes a slingbody having an intermediate portion and two end portions and a suture,wherein the suture extends through the sling body. The suture furtherprovides an adjustment loop proximate to the intermediate portion forpostoperative adjustment. Preferably, the sling is body is sized andshaped so at to minimize excess body from spanning through anatomicalspaces where it not needed for the treatment of incontinence.

In another form, the present invention provides a needle delivery devicefor implanting a medical device for the treatment of stress urinaryincontinence. The needle delivery device has a needle body, wherein theneedle body includes an aperture configured to receive a suture end ofthe medical device, and a lumen extending through the length of theneedle body, wherein the lumen is adapted to deliver a fluidtherethrough. Accordingly, in use, the needle delivery device cansimultaneously deliver a local anesthesia while implanting the medicaldevice through a precise anatomic pass with the needle body.

In yet another form, the present invention provides a method forimplanting a medical device to treat urinary incontinence in a human oranimal subject. The method includes the steps of making an incision inthe vaginal or perineal area; inserting first and second needles intothe human or animal subject; guiding the needles to the appropriate areain the groin or suprapubic area while simultaneously injecting a localanesthetic with the needles; removing the needles; positioning thesling; and leaving at least a portion of the sling (such as thetensioning suture) accessible for post-operative adjustment of thesling.

In another form, the present invention provides a kit for the treatmentof urinary incontinence. The kit includes a suburethral sling, a pair ofneedle delivery devices, wherein each needle delivery device isconfigured to simultaneously deliver local anesthesia and implant thesling around the urethra, and a finger guard.

These and other aspects, features and advantages of the invention willbe understood with reference to the drawing figures and detaileddescription herein, and will be realized by means of the variouselements and combinations particularly pointed out in the appendedclaims. It is to be understood that both the foregoing generaldescription and the following brief description of the drawings anddetailed description of the invention are exemplary and explanatory ofpreferred embodiments of the invention, and are not restrictive of theinvention, as claimed.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 depicts a front view of a sling in accordance with a firstexample embodiment of the present invention.

FIG. 2 depicts a front view of an end portion of the sling of FIG. 1.

FIG. 3 depicts a front view of a modified end portion of the sling ofFIG. 1.

FIG. 4 depicts a perspective view of a sling in accordance with a secondexample embodiment of the present invention.

FIG. 5 depicts a perspective view of a sling in accordance with a thirdexample embodiment of the present invention.

FIG. 6 depicts a perspective view of a sling in accordance with a fourthexample embodiment of the present invention.

FIG. 7 depicts a front view of a sling in accordance with a fifthexample embodiment of the present invention.

FIG. 8 depicts a perspective view of a sling in accordance with a sixthexample embodiment of the present invention.

FIG. 9 depicts a perspective view of a needle delivery device fordelivering a sling according to an example embodiment of the presentinvention.

FIG. 10 depicts a detailed view of the tip of the needle delivery deviceof FIG. 9.

FIG. 11 depicts a perspective view of the handle of the needle deliverydevice of FIG. 9 and shown with a portion of its housing removed.

FIG. 12 depicts a perspective view of a needle delivery device fordelivering a sling according to another example embodiment of thepresent invention.

FIG. 13 depicts a sectional view of the handle of the needle deliverydevice of FIG. 12.

FIG. 14 depicts a perspective view of a needle delivery device fordelivering a sling according to another example embodiment of thepresent invention.

FIG. 15 depicts a perspective view of a needle body for delivering asling according to another example embodiment of the present invention.

FIG. 16 depicts a sectional view of the handle of the needle deliverydevice of FIG. 14.

FIG. 17 depicts a perspective view of a handle for a needle deliverydevice of the present invention according to another example embodiment.

FIG. 18 depicts a perspective view of a handle for a needle deliverydevice of the present invention according to yet another exampleembodiment.

FIG. 19 depicts a perspective view of a portion of a guidewire for usewith a needle of the present invention and shown receiving a suture endof a sling of the present invention.

FIG. 20 depicts a side view of a guidewire and suture end of a slingaccording to another example embodiment of the present invention.

FIG. 21 depicts a side view of a guidewire and suture end of a slingaccording to yet another example embodiment of the present invention.

FIGS. 22 and 23 depict perspective views of a guidewire and suture endof a sling according to another example embodiment of the presentinvention.

FIG. 24 depicts a perspective view of a guidewire and suture end of asling according to yet another example embodiment of the presentinvention.

FIG. 25 depicts a finger guard according to an example embodiment of thepresent invention for use with a needle of the present invention.

FIGS. 26-27 depict pictorial representations of a pair of needledelivery devices of the present invention used to implant a sling of thepresent invention in a male subject.

DETAILED DESCRIPTION OF EXAMPLE EMBODIMENTS

The present invention may be understood more readily by reference to thefollowing detailed description of the invention taken in connection withthe accompanying drawing figures, which form part of this disclosure. Itis also understood that this invention is not limited to the specificdevices, methods and conditions or parameters described and/or shownherein, and that the terminology used herein is for the purpose ofdescribing particular embodiments by way of example only and is notintended to be limiting of the claimed invention. Also, as used in thespecification including the appended claims, the singular forms “a”,“an” and “the” include the plural, and reference to a particularnumerical value indicates at least that particular value, unless thecontext clearly dictates otherwise. Ranges may be expressed herein asfrom “about” or “approximately” one particular value and/or to “about”or “approximately” another particular value. When such a range isexpressed, another embodiment includes from the one particular valueand/or to the other particular value. Similarly, when values areexpressed as approximations, by use of the antecedent “about”, it willbe understood that the particular value forms another embodiment.

The present invention provides a sling for treating incontinence and anapparatus for delivering the sling around a subject's urethra while atthe same time delivering local anesthesia along the tissue tract throughwhich the sling is delivered.

Referring now to the figures, FIG. 1-8 depict slings of the presentinvention according to various example embodiments. As shown in FIG. 1,the sling 10 includes a flexible body 12 having a single suture 14extending or woven through the body generally along the sling'slongitudinal axis 16. The suture 14 can be affixed to or formed as partof the body 12. The suture includes ends 18, 20 extending from lateralsides of the body 12 and an intermediate loop portion 22. The ends 16,18 are configured to secure the sling 10 in the subject as well as toadjust the tension of the sling. The loop 22 also is configured to aidthe practitioner in adjusting the tension of the sling 10 when it isimplanted and postoperatively. Although a single suture is discussedherein, a plurality of sutures can be used and be within the scope ofthe present invention. In such instances, the sutures can extend from apoint near the lateral edges of the body or multiple sutures can extendthrough the length of the body. Preferably, the suture 14 is constructedof a bioabsorbable material such as but not limited to PGA, PDS, PLGA,VICRYL™, and catgut. A bioabsorbable suture absorbs in the subject'sbody and avoids an additional visit to the practitioner to remove thesutures. Alternatively, the suture 92 can be constructed of anon-absorbable biocompatible material and removed at a future date (ornot removed at all).

Preferably, the body 12 of the sling 10 is symmetrically shaped aboutboth its longitudinal axis 16 and its transverse axis 24. As shown, thebody 12 has an intermediate or suburethral portion 26 and two end (orperiurethral) portions 28, 30. The intermediate portion 26 has agenerally elongated hexagonal like shape (i.e., elongated along thelongitudinal axis 16), while the end portions 28, 30 are strip-like andtaper to a width that is slightly larger than or the same size as thediameter of the suture 14. In alternative embodiments, the size andshape of the sling can vary. For example, the intermediate portion canhave a tapered oval shape (i.e., tapered in the direction along thelongitudinal axis). Additionally, it may be advantageous to implant alonger sling in a male subject and shorter sling in a female subject.However generally, the widths are approximately the same regardless ofwhether the sling is implanted in a male or female subject. For example,the width W₁ of the intermediate portion can be approximately 10 mm to40 mm. The widths W₂ of the end strips can be approximately 5 mm to 10mm. Advantageously, this construction minimizes the amount of the slingbody that is located in the anatomical spaces of the subject. For asling to be implanted in a female subject, the length of the body can bebetween approximately 3 cm to 13 cm, and preferably around 8 cm, withthe intermediate portion approximately 3-5 cm long. For a sling to beimplanted in a male subject, the length of the body can be betweenapproximately 12 cm to 22 cm, and preferably around 16 cm with theintermediate portion approximately 8-12 cm long. As shown, the endstrips taper at their lateral ends to a few millimeters, such as betweenabout 3 mm to 30 mm, and more preferably around 5 mm.

The body 12 is preferably constructed from a sheet-like material.Preferably, the sheet-like material comprises a biocompatible, surgicalmesh material such as polypropylene, that does not absorb in thesubject's body. Other exemplary biocompatible mesh materials includenylon, polyester, and polytetrafluoroethylene. In such embodimentsutilizing mesh, the sling 10 is held in appropriate placement in thesubject's body by the friction between the sling and the surroundingtissue. The subject's body forms scar tissue around and through the meshbody, thereby further securely holding the mesh body in place. However,other suitable biocompatible materials, including “non-mesh” materialscan be used as well. Alternatively, bioabsorbable materials such aspolyglycolic acid, polylactic acid, PEA, PEUR, PEG, and PLLA can beemployed.

Advantageously, when implanted in a human or animal subject, the slingbody preferably does not extend through the subject's skin. Rather, onlythe suture ends (which eventually absorb into the body) temporarilyextend through the patient's skin to thereby allow retensioning at afuture date. Accordingly, since the overall size of the sling body isreduced and therefore does not extend into anatomical spaces where itprovides no additional benefits for the treatment of incontinence,patient discomfort is significantly reduced.

Optionally, the sling body 12 can be constructed of a single size andshape that can be trimmed to an appropriate size and shape. The slingbody 10 has one or more sutures 14 secured at multiple points along thebody 12 of the sling. For example, the suture 14 can be attached to thebody 12 of the sling 10 (e.g., mesh sling) with multiple knots 32. Theplurality of knots 32 securing the suture 14 to the body 12 prevents thesuture from detaching from the sling body when the body is cut. Forexample, FIGS. 1 and 2 depict end strips 28 of the sling 10 having threesuch knots 32. Accordingly, the practitioner can cut the sling body 12,such as in the areas of lines 34 or 36, thereby removing segments of themesh body, to an appropriate size without detaching the suture 14 fromthe sling 10, so as to achieve the size shown in FIG. 3. The suture 14can be tied (or otherwise secured) to the sling body with any suitablenumber of knots. Thus, the practitioner can cut the sling body to anysuitable size and shape without disengaging the suture from the body.

FIGS. 4-8 show additional sling embodiments. For example, FIGS. 4 and 5show slings 50, 60 having substantially the same size and shape as thatof FIG. 1, but the end strip portions taper from the intermediateportion to a tip that is the same size as or slightly larger than thediameter of the suture ends. The notable difference between FIGS. 4 and5 is that in FIG. 4, the suture 52 is woven through the length of thebody 54, while in FIG. 5, the suture 62 is woven through end strips 64,66 of the body, but at the suture extends across an external face of theintermediate portion with its loop 68 extending through an opening andprotruding from the opposite face. Otherwise, the slings 50, 60 aresubstantially similar to that of FIGS. 1-3, but with the differencesnoted above.

FIG. 6 depicts a sling 70 according to another example embodiment. Thesling 70 is substantially similar to that of FIGS. 1-5, but with thedifferences noted herein. In this embodiment, the body 72 smoothlytapers to its lateral ends in a manner somewhat like the shape of ateardrop.

FIG. 7 depicts a sling 80 according to yet another example embodiment.The sling 80 is substantially similar to that of FIGS. 1-6, but with thedifferences noted herein. In this embodiment, the body has generally atwo-piece construction having first and second spaced-apart members 82,84. As depicted a first suture 86 is affixed to or formed as part of thefirst member 82, and a second suture 86 is affixed to or formed as partof the second member 84. The first and second members 82, 84 areconnected by at least one and preferably two sutures 88, 89. Preferably,the two sutures 88, 89 connecting the first and second members 82, 84are not bioabsorbable. Alternatively, the two sutures 88, 89 connectingthe first and second members 82, 84 can be constructed of abioabsorbable material. Also preferably, the first and second members82, 84 are spaced apart a sufficient distance such that once implantedin a human or animal subject, the first and second members are notplaced beneath the urethra of subject, but rather are placed towards thesides (in the periurethral space). Even though the first and secondmembers 82, 84 are depicted as generally elongated triangular-likeshapes with rounded base portions, any suitably sized and shaped memberscan be employed.

FIG. 8 depicts a sling 90 according to yet another example embodiment.The sling 90 is substantially similar to that of FIGS. 1-7, but with thedifferences noted herein. The sling includes a sheath 90 (or tubing)that covers and protects the body of the sling during implantation(i.e., passage through a needle body). The sheath 92 is the removed intwo parts 92 a, 92 b, thereby exposing the sling body and allowing forfinal tensioning and positioning.

As shown in FIGS. 9-18, a needle delivery device can be used to implanta sling of the present invention in appropriate placement around theurethra while also delivering a sufficient amount of fluid, such as alocal anesthetic (e.g., lidocaine). Preferably, a pair of needledelivery devices is used simultaneously and manipulated independently ofeach other. The two needle delivery devices are substantially similar toone another and preferably are mirror images of one another, and thus,only one needle delivery device of the pair will be discussed in detailherein. Thus, the practitioner would use the appropriate one of theneedle delivery devices in his left hand and the other in his righthand. As discussed below, the needle delivery device can include avariety of shapes including, arcuate, curved, spiral, helical, orstraight.

Advantageously, the practitioner makes “one pass” with the needle bodiesof the needle delivery devices. In other words, the practitioneradvances the needle bodies into the subject's anatomical space whilesimultaneously delivering both local anesthesia and a sling of thepresent invention. Accordingly, as the needle bodies are advanced intothe anatomical spaces, trauma to surrounding tissue is minimized.

In a first example embodiment depicted in FIGS. 9-11, a needle deliverydevice 100 includes a needle body 102 having a sharp tip 104 at itsdistal end and having a lumen 106 extending through the length of thebody. The tip 104 includes an aperture 108 therethrough that is sizedand shape to accommodate a suture end of a sling of the presentinvention. As depicted, the body 102 is a generally elongated body withan arcuate, curved, or somewhat helical or spiral portion. Preferably,the body 102 is sized and shaped to allow a practitioner to navigatearound the pubic ramus for the transobturator approach, or the pubicbone lateral to the symphysis for the retropubic approach.

The needle body 152 preferably includes three segments: a tip segment103, a loop segment 105, and a proximal segment 107. Preferably, the tipsegment 103 and the loop segment 105 form a continuous curvature loopthat spans about 180° in the x-z plane. In alternative embodiments, thecurvature of the loop can span about 120° to about 240° in the x-zplane. Preferably, the proximal segment 107 is a generally straightsegment extending along the y-axis. Also preferably, the tip segment 103is a generally straight segment extending along the x-axis, which isgenerally perpendicular to the y-axis.

Preferably, the needle body 102 and the tip 104 are fabricated from abiocompatible and rigid material, such as stainless steel, and can begenerally smooth and polished on their exterior to facilitatepenetration of soft tissue. In an example embodiment, the needle bodyhas a gauge of between 10-25, although other suitable gauges of needlebodies can be employed as well. The length of the body 102 is preferablysufficient to reach from the subject's urethra to an insertion site atthe skin (typically in either the groin or abdomen). Accordingly, thelength of the needle body can be between approximately 3 cm toapproximately 20 cm.

At the proximal end of the needle body 102 is a handle 110. Preferably,the handle 110 is an ergonomically shaped handle that provides apractitioner the ability to easily manipulate the needle delivery devicewith his hand. As shown in FIGS. 9 and 11, the handle 110 has agenerally elongated body 112 having a generally bulbous member 114 atits proximal end. The bulbous member 114 can include one or more fingergrips 116. An elongated slot 118 extends from the handle's distal end tothe bulbous member 114.

Within the bulbous member 114, as shown more clearly in FIG. 11, is anassembly 120 for injecting a fluid through the needle body 102. Theassembly 120 includes a receiver 122 for receiving a syringe 124prefilled with fluid. The fluid can include, but is not limited to, alocal anesthetic (e.g., lidocaine), another medication, or a salinesolution. The syringe 124 includes a reservoir of fluid (not shown), aplunger 126 at one end, and a port (not shown) at the other that is influid communication with the lumen 106 of the needle body 102.Preferably, the coupling between the syringe's port and the lumen 106prevents leakage. When depressed, the plunger 126 forces the fluidthrough the port and into the lumen 106 of the needle body 102.Optionally, a one way valve (not shown) can be located between thesyringe's port and the needle's lumen 106 so as to prevent fluid in theneedle's lumen from returning to the syringe's reservoir. The receiver122 is mechanically coupled to the body 112 of the handle 110 (such aswith fasteners) so as to retain the syringe 124 therein and to hold theport of the syringe in fluid communication with the lumen 106 of theneedle body 102. Those skilled in the art will understand that thereceiver 122 can be sized and shaped to accommodate a suitable syringe.

As shown, the plunger 126 of the syringe 124 somewhat extends beyond thewall of the slot 118 such that the practitioner can manipulate thehandle 110 and depress the plunger with a thumb or finger. Accordingly,the practitioner can continuously control how much fluid is injected ashe guides the needle body 102 through the anatomical space of thesubject. In an alternative embodiment, the receiver includes a reservoirfor housing a sufficient amount of fluid and a plunger for dispensingthe fluid through a port of the reservoir. Thus in this embodiment, aseparate syringe is not used.

In another example embodiment as depicted in FIGS. 12-13, a needledelivery device 150 includes a generally helical or spiral shaped body152, which is substantially similar to that shown in FIG. 9. The needlebody 152 has a sharp tip 154 having a trigger-operated handle 156 toinject a fluid. Preferably, the diameter D of the curved/helical portionof the needle body 152 is approximately between 2 cm and 10 cm. Theneedle body 152 preferably includes three segments: a tip segment 153, aloop segment 155, and a proximal segment 157. Preferably, the tipsegment 153 and the loop segment 155 form a continuous curvature loopthat spans about 180° in the x-z plane and about 90° in the y-z plane.In alternative embodiments, the curvature of the loop can span about120° to about 240° in the x-z plane. Preferably, the proximal segment157 is a generally straight segment extending along the y-axis. Alsopreferably, the tip segment 153 is a generally straight segmentextending along the x-axis, which is generally perpendicular to they-axis.

Additionally, the needle body 152 and the tip 154 are fabricated from abiocompatible and rigid material, such as stainless steel, and can begenerally smooth and polished on their exterior to facilitatepenetration of soft tissue. Additionally, as shown in FIG. 12, the body154 includes a lumen 158 and an aperture 160 at the tip 154.

FIG. 13 depicts the internal mechanics of the handle 156. The handle 156includes a housing 162 and a dispensing assembly 163. The dispensingassembly 163 includes a user-operated trigger 164 extending through thehousing and in communication with a fluid chamber or compartment 166.The trigger 164 provides the practitioner a way to release a fixeddosage or amount of medication (or other fluid) through the lumen 158 ofthe needle body 152. The trigger 164 is in mechanical communication withthe fluid chamber 166. Preferably, the chamber 166 can be constructed ofmaterial that flexes or compresses. The trigger 164 is mechanicallycoupled through linkage 168 to a pivotal lever 170 that is locked inplace with a toothed ratchet rack 172 (i.e., a generally linear ratchetrack). The ratchet rack 172 has a flanged end 174 protruding through thehousing 162 of the handle 156 and engaged by the free end of the trigger164. A user-operated button 176 coupled to the lever provides a releasefor permitting the lever 170 to advance in a backwards (or reverse)direction (so as to expand the chamber)

Thus, when the trigger 164 is activated, the lever 170 compresses thechamber 160 by a fixed amount and the end of the lever advances onetooth of the linear rack 172. In this sense, the end of the lever 170functions like a pawl. As the chamber 166 is compressed, the fluidtherein is forced out through the exit port 178 of the handle 156 andinto the lumen 158 of the needle body 102 in a predetermined dosage.Each time the trigger 164 is activated, a predetermined dosage of fluidis released. In an alternative embodiment, the lever forms one wall ofthe chamber. Thus, as the lever advances, the chamber's volume becomessmaller.

In the depicted embodiment of FIGS. 12 and 13, the fluid chamber can berefilled. Preferably, the practitioner simultaneously presses the button168 and pulls the flanged end 174 of the ratchet rack 172. In so doing,the dispensing assembly 163 is returned to its initial state where thechamber 166 is fully expanded. The practitioner can remove the stopper180 from an opening of the handle, inject an adequate amount of fluid,and reattach the stopper. Optionally, a one way valve (not shown) can belocated adjacent the exit port so as to prevent fluid in the needle'slumen from returning to the fluid chamber.

FIGS. 14 and 16 depict another example embodiment of a needle deliverydevice 200 of the present invention. The needle delivery device has agenerally curved body 202 having a sharp tip 204 and a trigger-operatedhandle 206 to inject a fluid. Alternatively, the needle body 202′ can beshaped/curved as shown in FIG. 15 (such as for use with a retropubicapproach). Additionally, as shown in FIG. 14, the body 204 includes alumen 208. The needle body 202 and tip 204 are constructed from suitablematerials of suitable sizes as discussed above.

FIG. 16 depicts the inner mechanics of the handle 206. The handle 206includes a housing 216 and a dispensing assembly 218. The dispensingassembly 218 includes a user-operated trigger 220 extending through thehousing 216 and in communication with a fluid chamber or compartment222. The fluid chamber 222 includes a piston 224 for dispensing thefluid out through the exit port 226. The piston 224 is coupled tomechanical linkage 228 having an end portion 230 extending through thehousing 216. The end portion 230 is configured to be engaged by thetrigger 220. Thus, activation of the trigger 220 engages the end portion230 of the mechanical linkage 228 and causes the piston 224 to move intothe fluid chamber 222, thereby dispensing a portion of the fluid thereinthrough the exit port 226.

The fluid chamber 222 is further in fluid communication with a reservoir232 containing additional fluid. The fluid chamber 222 can be coupled tothe reservoir 232 with a tube 234. A one way valve (not shown) can beattached to the tube 234 so as to prevent fluid from returning to thereservoir 232. A second one way valve (not shown) can be locatedadjacent the exit port 226 so as to prevent fluid in the needle's lumen208 from returning to the fluid chamber 222. To refill the reservoir232, the practitioner removes the stopper 236, injects a suitable amountof fluid through the opening in the housing 216, and replaces thestopper.

Another example embodiment of a handle 250 is shown in FIG. 17. Thehandle 250 comprises a generally ergonomically shaped and substantiallyrigid housing 252 having an injection port 254 coupled to an exit port256 near its distal end. A syringe 258 of fluid having an associatedplunger 260 is coupled to the injection port 254. The exit port 256 iscoupled to a needle body of the present invention such that the exitport is in fluid communication with the needle's lumen. Upon depressionof the plunger 260, fluid flows from the syringe 258 through theinjection port 254, out through the exit port 256, and into the lumen ofthe needle body. The injection port 254 and associated syringe 258 canbe located at any suitable place along the housing.

Another example embodiment of a handle 270 is shown in FIG. 18. Thehandle 270 includes a substantially rigid housing 272 having an opening274 for exposing a portion of a flexible reservoir 276. The handle 270further includes an exit port 278 in fluid communication with a lumen ofa needle body of the present invention. Upon depression of the flexiblereservoir 276, fluid is forced out of the exit port 278 and into thelumen of the needle body. Although the reservoir 276 depicted in FIG. 18is a flexible container housed within a rigid housing 272, the inventionincludes embodiments wherein a first portion of the housing can besubstantially rigid while a second portion is substantiallycompressible. Still alternatively, the entire handle can be made of aflexible or compressible material such that as the handle is squeezed,fluid is forced out of the export port.

Any of the handles of the present invention can be combined with any ofthe needle bodies of the present invention, and the invention includessuch embodiments.

Referring back to FIG. 14, the needle body 202 can include a smallopening 300 in the wall that is sized and shaped to receive a guidewire302 therethrough, as shown in FIG. 19. Preferably, the opening 300 islocated near the handle 206, although the opening can be placed at anysuitable location along the body 202. In such an embodiment, thepractitioner can place his finger or thumb over the opening 300 wheninjecting the fluid so as to prevent the fluid from exiting the opening300. Alternatively, the needle body can include two lumens, one fordelivering the anesthesia and the other for delivering the sling.Alternatively or additionally, the opening in the needle body caninclude a flap for preventing fluid leakage therethrough.

Preferably, the guidewire 302 is constructed of a durable yet flexiblematerial that can be threaded through the needle body. For example, theguidewire 302 can be constructed from a plastic or metal wire. Inaddition, the guidewire 302 can be placed through the tip 104 of aneedle body (such as the needle delivery device 100 of FIG. 9) into thelumen 106 and out the opening 300. After passage of the guidewire 302,the needle body 102 can be removed and therefore the end of theguidewire can be fastened or otherwise secured to the sling 10 and/orsuture 14, using the general principles of the Seldinger Technique.

As depicted in FIG. 19, the guidewire 302 can include an eyelet 304 atits distal end. Preferably, the eyelet has a size and shape that issuitable to receive a suture end of a sling of the present invention,such as suture end 18. Accordingly, the guidewire 302 can be insertedthrough the opening 300 (or tip end) of the needle body 202, into thelumen 208, and advanced to the needle's tip 204 (or to the opening 300).As the guidewire 302 is inserted into needle body 202, the eyelet 304collapses, allowing it to be threaded through the needle body moreeasily. Preferably, the eyelet 304 of the guidewire 304 is insertedthrough the opening (or tip end) first, although those skilled in theart will understand that the opposite end of the guidewire can beinserted through the opening or tip end.

FIGS. 20-24 depict several guidewires according to various exampleembodiments of the present invention. Each of the guidewires includes anattachment feature for securely grasping a suture end of the sling ofthe present invention. For example in FIG. 20, the guidewire 320includes an anchor 322 at a distal end thereof that can mate with acoopering portion 324 of a suture end 326 of a sling of the presentinvention. As shown in FIG. 20, the cooperating portion 324 can includean anchor seat in which the anchor is securely housed. Once theguidewire 320 and suture end 326 are pulled through a needle body of thepresent invention and the sling is at least somewhat around the urethraor in an otherwise appropriate placement, the practitioner can disengagethe guidewire from the suture end by pulling the two apart. FIG. 21depicts a guidewire 330 according to an alternative embodiment having ananchor 332 that mates with an anchor seat 334 of a suture end 336 of asling. Although the anchors are described as being a part of theguidewire, in an alternative embodiment, the anchors can be a part ofthe suture end.

In FIGS. 22 and 23, a suture end 340 of the sling includes a threadedfemale member 342 attached thereto. A guidewire 344 can include acooperating threaded end 346 that mates with the threaded female memberof the suture end. Once the guidewire 344 and suture end 340 are pulledthrough a needle body of the present invention and the sling is at leastsomewhat around the urethra or otherwise in appropriate placement, thepractitioner can cut the suture end to remove the threaded female memberor can otherwise disengage the threaded female member from the sutureend. Although the threaded female member is described as being a part ofthe suture end, in an alternative embodiment, the threaded female membercan be a part of the guidewire.

In FIG. 24, a guidewire 350 includes a clamp 352 for securely gripping asuture end 354 of a sling of the present invention. The suture 354 endcan be inserted into the clamp 352, and the clamp can be closed (bysqueezing the clamping members together). Once the guidewire 350 andsuture end 354 are pulled through a needle body of the present inventionand the sling is at least somewhat around the urethra (or otherwiseplaced in an appropriate placement), the practitioner can disengage thesuture end 354 from the guidewire 350 by opening the clamp 352 andreleasing the suture end. Although the clamp is described as being apart of the guidewire, in an alternative embodiment, the clamp can be apart of the suture end.

FIG. 25 depicts a finger guard 360 for use with the needle deliverydevices of the present invention. The finger guard is sized and shapedto cover at least a fingertip (or thumbtip) of the practitioner.Preferably, the finger guard 360 is constructed from a punctureresistant material, such as ballistic nylon, although other suitablematerials can be employed as well. In use, the practitioner places thefinger guard 360 over one his fingers or thumbs. Thus, as thepractitioner is guiding a needle body from a point external to thesubject's body to an area of a premade incision, the practitioner canfeel the placement of the sharp tip of the needle without risking beinginjured.

In use, a practitioner uses a pair of needle delivery devices of thepresent invention to implant a sling of the present invention inappropriate placement (such as around a subject's urethra) while usingthe same needle delivery devices to simultaneously deliver a localanesthetic along the insertion tract. The following method is describedin terms of the sling 10 of FIG. 1 and the needle delivery device 100 ofFIGS. 9-11. However, those skilled in the art will understand that anyof the slings and needle delivery devices of the present invention canbe employed and be within the scope of the present invention.

When implanting the sling 10 in a female subject in a first exampleembodiment, the practitioner initially applies a local anesthetic andmakes a small incision or stab wound in the vaginal area. Thepractitioner threads the first suture end 18 of the sling 10 through theaperture 108 of the first needle delivery device 100 and the secondsuture end 20 of the sling through the aperture 108 of the second needledelivery device. The practitioner inserts the first and needle deliverydevices 100, each carrying a portion of the sling 10, through thevaginal incision. The practitioner injects the local anesthetic from thehandle reservoirs by depressing the plungers 126 as he advances theneedles 100 behind the pubic ramus and generally in a direction towardsan appropriate area of groin skin or suprapubic region.

Alternatively if a needle is used having an aperture at a location otherthan the tip of the needle such as needle 200, once the tips 208 of theneedles protrude through the skin in the groin or suprapubic region, thepractitioner threads a guidewire, such as guidewire 302 into the lumen208 at the tip 204 of the first needle 200. When the eyelet 304 of theguidewire 302 is located near the vaginal incision, the practitionerholds the eyelet while removing the needle 200 from the subject's body.The steps of threading the guidewire through the needle and removing theneedle from the body are repeated for the second needle. Thus, the twoeyelets 304 of the two guidewires 302 are now located near the vaginalincision. The practitioner threads the first suture end 18 of the sling10 through the eyelet 302 of the first guidewire 304 and the secondsuture end 20 of the sling through the eyelet of the second guidewireand then pulls the guidewires and hence the sling into placement.

Regardless of whether the practitioner uses the needles or guidewires topull the sling, the practitioner manipulates the proximal ends of theneedle delivery devices or guidewires so as to remove the needles orguidewires from the subject through the reverse path. Once the needles(or guidewires) exit the body, the practitioner removes the suture endsfrom the needles (or guidewires) and positions the intermediate portion26 of the sling underneath the urethra and positions the adjustment loop22 accordingly. The practitioner adjusts the tension on the sling, cutsthe suture ends to about 5 cm long, and secures the suture ends to thesubject at a point external to the subject's body. For example, thesuture ends 18, 20 can be secured beneath suitable bandages, such asTAGADERM™ dressings. Before closing the incision in the vaginal wall,the practitioner can either superficially bury the loop 22 of the sling10 in the incision or can close the incision in such a manner that atleast a portion of the loop 22 protrudes through the incision foradjusting the tension of the sling 10 after the procedure.

Within about 24-48 hours after the procedure, the practitioner canreadjust the sling 10. The slings of the present invention can beadjusted up to about seven days or so after the procedure. Optionally,the practitioner can use a urethral dilator to provide counter-traction.The practitioner removes the bandages covering the suture ends 18, 20and manipulates the suture ends and/or loop 22 of the sling 10(currently located near the site of the vaginal incision). Pulling onthe suture loop 22 loosens the sling 10 around the urethra, whilepulling on the suture ends 18, 20 tightens the sling around the urethra.Once proper tensioning is established, the practitioner trims sutureends at skin level and cuts the adjustment loop at the midline vaginalincision.

When implanting the sling 10 in a male subject, the subject is firstplaced in a high lithotomy position. A Foley catheter is placed throughthe subject's urethra and into his bladder. The practitioner applies alocal anesthetic such as lidocaine and makes a small incision or midlinestab wound in the perineum. The practitioner creates subcutaneous spaceswith metzenbaum scissors, lateral to the midline urethra on each side.The practitioner inserts the first needle body 102 through the perinealincision, and passes the needle body 102 through the obturator foramen,to the appropriate area on the subject's groin. The second needle bodyis passed on the contralateral side, as shown in FIG. 26. Thepractitioner injects the local anesthesia from the handle reservoirs bydepressing the plungers 126 as he advances the needles from inside theperineal incision, through the obturator foramen, and out at theipsilateral groin. Prior to passage of each needle, the practitionerthreads the suture ends 18, 20 of the sling 10 through the aperture 108of each needle body 102; thus, the suture 14 is carried, as anestheticis simultaneously delivered, along this tract leading up to the groin.Once the tips 104 of the needles 100 protrude through the groin skin,the suture ends 18, 20 are freed from the needles, and the needles areremoved through the perineal incision, leaving only the sling body(e.g., mesh) and suture ready for tensioning.

Alternatively, if a needle is used having an aperture at a locationother than the tip of the needle such as needle 200, once the tips 204of the needles 200 protrude through the groin skin, the practitionerthreads a guidewire from outside the groin skin, such as guidewire 302,through the aperture 300 of the first needle. When the eyelet 304 of theguidewire 302 exits near the incision in the perineal wall, thepractitioner holds the eyelet while removing the needle from thesubject's body. The steps of threading the guidewire through the needleand removing the needle from the body are repeated for the secondneedle. Thus, the two eyelets 304 of the two guidewires 302 are nowlocated near the perineal incision. The practitioner threads the firstsuture end 18 of the sling 10 through the eyelet 304 of the firstguidewire 302 and the second suture end 20 of the sling through theeyelet of the second guidewire.

Regardless of whether the practitioner uses the needles or guidewires topull the sling, the practitioner manipulates the proximal ends of theneedle delivery devices or guidewires so as to remove the needle bodiesor guidewires from the subject through the reverse path. Thepractitioner positions the intermediate portion 26 of the slingunderneath the urethra and/or the perineal body and positions theadjustment loop 22 accordingly, as generally shown in FIG. 27. Once theneedles (or guidewires) exit the subject's body, the practitionerremoves the suture ends 18, 20 from the needles (or guidewires) andadjusts the tension and placement of the sling. For example, thepractitioner can ask the subject to cough (or otherwise engage thesubject in an activity that causes intraabdominal pressure) as he isadjusting the tension of the sling 10. The practitioner cuts the sutureends 18, 20 to about 5 cm long and secures the suture ends to thesubject at a point external to the subject's body. For example, thesuture ends 18, 20 can be secured beneath suitable bandages, such asTAGADERM™ dressings. The practitioner can place a steristrip or sutureover the stab wound in the perineal wall such that a portion of theadjustment loop 22 extends through the wound.

Within about 24-48 hours or up to a week or so after the procedure, thepractitioner can readjust the sling 10, after the patient has assessedits efficacy and voiding function during activities. The practitionerremoves the bandages covering the suture ends 18, 20 and manipulates thesuture ends and/or loop 22 of the sling 10 at the site of the perinealincision. Pulling on the suture loop 22 loosens the sling 10 around theurethra, while pulling on the suture ends 18, 20 tightens the slingaround the urethra. To aid in the adjustment of the tensioning, thepractitioner can ask the subject to cough (or otherwise engage thesubject in an activity that causes intraabdominal pressure) as he isadjusting the tension of the sling 10. Once proper tensioning isestablished, the practitioner trims suture ends 18, 20 at skin level andcuts the adjustment loop at the midline vaginal incision.

Although the present invention is described in terms of “inside-out”methods of implanting slings in female and male subjects, the methods ofthe present invention can be adapted to provide “outside-in methods” forboth female and male subject and be within the scope of the presentinvention. For example, the practitioner can insert the first needlebody 102 through a female subject's abdomen or groin and the secondneedle body 102 through the subject's abdomen or groin. The practitionercan inject the local anesthetic from the handle reservoirs by depressingthe plungers 126 as he advances the needle bodies 102 generally in adirection towards the premade vaginal incision. Once the tips 104 of theneedles protrude through the vaginal incision, the practitioner canthread the first suture end 18 of the sling 10 through the aperture 108of the first needle and the second suture end 20 of the sling throughthe aperture 108 of the second needle. The practitioner can manipulatethe proximal ends of the needle delivery devices so as to remove theneedle bodies the subject through the reverse path. In so doing, thepractitioner is simultaneously pulling the suture ends 18, 20 of thesling 10 through the passages initially created by the needles as theneedles are removed from the subject's body.

Additionally, other suitable methods of implanting the sling can be usedand be within the scope of the present invention.

In another form, the present invention provides a kit for the treatmentof urinary incontinence. The kit can include one, and preferably two,needle delivery devices of the present invention, a sling of the presentinvention, and a finger guard of the present invention. Optionally, thekit can include one or more syringes or vials of local anesthetic, oneor more bandages, and one or more guidewires of the present invention.

While the invention has been described with reference to preferred andexample embodiments, it will be understood by those skilled in the artthat a variety of modifications, additions and deletions are within thescope of the invention, as defined by the following claims.

1. An apparatus for the treatment of stress urinary incontinence,comprising: a sling body having an intermediate portion and two endportions, and a suture, wherein the suture extends through the slingbody and wherein the suture provides an adjustment loop proximate theintermediate portion for postoperative adjustment.
 2. The apparatus ofclaim 1, wherein the suture has free ends, each extending from an endportion.
 3. The apparatus of claim 2, wherein the free ends are at least5 cm long.
 4. The apparatus of claim 1, wherein the suture is secured tothe body with a plurality of knots.
 5. The apparatus of claim 1, whereinthe suture is bioabsorbable.
 6. The apparatus of claim 1, wherein thesling body is constructed of a surgical mesh material.
 7. A needledelivery device for implanting a medical device, comprising: a needlebody, wherein the needle body includes an aperture configured to receivea suture end of the medical device; and a lumen extending through thelength of the needle body, wherein the lumen is adapted to deliver afluid therethrough.
 8. The needle delivery device of claim 7, furthercomprising a handle, wherein the handle includes a supply of localanesthetic in fluid communication with the lumen.
 9. The needle deliverydevice of claim 8, wherein the handle includes a trigger for releasingan amount of the local anesthetic.
 10. The needle delivery device ofclaim 8, wherein the aperture is located proximate the handle.
 11. Theneedle delivery device of claim 7, wherein the needle body furtherincludes a tip and wherein the aperture extends through at least aportion of the tip.
 12. A method for implanting a sling to treat urinaryincontinence in a human or animal subject, comprising: making anincision in the perineal or vaginal area; inserting first and secondneedles, each carrying a portion of the sling, into the human or animalsubject; guiding the needles carrying the sling to an appropriate sitein the groin or suprapubic area while simultaneously injecting localanesthesia through the needles; removing the needles; positioning thesling; and leaving at least a portion of the sling accessible forpost-operative adjustment of the sling.
 13. The method of claim 12,wherein the sling includes a suture having two free ends and wherein thestep of leaving at least a portion of the sling accessible forpost-operative adjustment of the sling further includes leaving the twofree ends of the suture external to the subject's body.
 14. The methodof claim 12, wherein the sling includes a suture having an adjustmentloop and wherein the step of leaving at least a portion of the slingaccessible for post-operative adjustment of the sling further includesleaving the adjustment loop accessible.
 15. The method of claim 12,further comprising adjusting the sling's tension post-operatively bymanipulating the accessible portion of the sling.
 16. A kit for thetreatment of urinary incontinence, comprising: a suburethral sling; apair of needle delivery needles, wherein each needle delivery needle isconfigured to deliver local anesthesia and to implant sling around theurethra; and a finger guard, wherein all of the above items are packagedtogether in the kit.